Pregnancy and breastfeeding risk categories: Medicines B
From bacitracin to butorphanol, learn more about the safety of the most common medications during pregnancy and lactation with the following general overview of medications that start with the letter B.
Pregnancy risk categories
A. Controlled studies show no risk
Adequate, well-controlled studies in pregnant women have shown no risk to the fetus in any trimester of pregnancy.
B. No evidence of risks in humans
Adequate, well-controlled studies in pregnant women have shown no increased risk of fetal abnormalities, despite negative findings in animals, or, in the absence of adequate human studies, animal studies show no fetal risk. The likelihood of fetal damage is low, but remains a possibility.
C. Risk cannot be excluded
Adequate, well-controlled human studies are lacking, and animal studies have shown a risk to the fetus or not. There is a possibility of fetal harm if the drug entocort is administered during pregnancy, but the potential benefits may outweigh the potential risks.
D. Positive indications of a risk
Human studies or test data or post-marketing data have demonstrated fetal risk. Still, potential benefits from using the drug can outweigh the potential risk. For example, the entocort drug may be acceptable if needed in a life-threatening situation or serious illness for which safer drugs cannot be used or are ineffective.
X. Contraindicated in pregnancy
Animal or human studies or examination or post marketing reports have shown positive evidence of fetal anomalies or risks that far outweigh the potential benefits to the patient.
Breastfeeding risk categories
Drug that has been taken by a large number of nursing mothers with no observed increase in side effects in infants. Controlled studies in breastfeeding women show no risk to the child and the possibility of harm to the breastfeeding infant is removed, or the product is not orally bio available in an infant.
L2. More secure
Drug that has been studied in a limited number of breastfeeding women without increasing the side effects in the infant; and / or, evidence of a proven risk likely to follow the use of this medication in a breastfeeding woman has been removed.
L3. Moderately safe
There are no controlled studies in breastfeeding women; however, the risk of adverse effects on a breastfed child is possible; or, controlled studies show minimal, non-threatening side effects and vomiting. Medications should only be administered if the potential benefit justifies the potential risk to the child.
L4. Possibly dangerous
There is positive evidence of a risk to a breastfed child or breast milk production, but the benefits of using it in breastfeeding mothers may be acceptable to the child despite the risk (e.g. if the drug is in a life-threatening situation or for a serious illness is needed for which safer drugs like Fioricet cannot be used or are ineffective).
Studies in nursing mothers have shown that there is a significant and documented risk to the child based on human experience, or it is a drug that is at high risk of causing nausea and significant harm to an infant. The risk of using the drug in women who are breastfeeding clearly outweighs any benefits from breastfeeding. The drug is contraindicated in women who are breastfeeding a child.
Disclaimer: The information provided in this article is not intended to replace professional medical advice from your doctor. For detailed information on certain medications or for information on medicines not listed, please contact your doctor.